Evaluation of Double Tract Reconstruction After Total Gastrectomy in Patients With Gastric Cancer
A Prospective Randomized Controlled Trial Comparing Double Tract Method With Roux-en-Y Method After Total Gastrectomy in Patients With Gastric Cancer
1 other identifier
interventional
44
1 country
1
Brief Summary
The purpose of this study is to evaluate the double tract reconstruction after total gastrectomy in patients with gastric cancer. A prospective randomized controlled trial was conducted to compare double tract method with Roux-en-Y method
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 gastric-cancer
Started Apr 2002
Typical duration for phase_3 gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 2, 2008
CompletedFirst Posted
Study publicly available on registry
September 3, 2008
CompletedSeptember 4, 2008
September 1, 2008
5.8 years
September 2, 2008
September 3, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The %body weight ratio
12 months after operation
Secondary Outcomes (1)
preoperative complication, PNI and QOL score
within one month, and 3 and 12months after operation
Study Arms (2)
1
ACTIVE COMPARATORRoux-en-Y
2
EXPERIMENTALdouble tract reconstruction
Interventions
Eligibility Criteria
You may qualify if:
- Histologically proven adenocarcinoma without esophageal invasion, tumor status T1-2
- Age 80 years or younger
- No distant metastasis
You may not qualify if:
- Carcinoma in the remnant stomach
- Stage intravenous (IV)
- History of laparotomy
- History of serious heart disease
- Liver cirrhosis or chronic liver disease with indocyanine green excretion test at 15 min of 15% or more
- Absence of informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Second Department of Surgery, Wakayama Medical University
Wakayama, Wakayama, 641-8510, Japan
Related Publications (1)
Iwahashi M, Nakamori M, Nakamura M, Naka T, Ojima T, Iida T, Katsuda M, Ueda K, Yamaue H. Evaluation of double tract reconstruction after total gastrectomy in patients with gastric cancer: prospective randomized controlled trial. World J Surg. 2009 Sep;33(9):1882-8. doi: 10.1007/s00268-009-0109-0.
PMID: 19548028DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Makoto Iwahashi
Second Department of Surgery, Wakayama Medical University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 2, 2008
First Posted
September 3, 2008
Study Start
April 1, 2002
Primary Completion
January 1, 2008
Study Completion
April 1, 2008
Last Updated
September 4, 2008
Record last verified: 2008-09